FDA.reportPublic FDA data

Aripiprazole

Product NDC
70518-2806
11-digit product format
705182806
Labeler code
70518
Product ID
70518-2806_4aa33a3e-5b27-2181-e063-6294a90a838b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207105
Marketing category
ANDA
Marketing start
2020-07-06
Substance
ARIPIPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aripiprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349553

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2806-0Aripiprazole30 in 1 BOXTABLET3015
70518-2806-1Aripiprazole1 in 1 POUCHTABLET115
70518-2806-2Aripiprazole30 in 1 BLISTER PACKTABLET3015
70518-2806-3Aripiprazole30 in 1 BLISTER PACKTABLET3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2806-2EA - Each70518-280676a7bbbd-24c8-48a1-8d52-16659cff2aef12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2806ARIPIPRAZOLE TABLET [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 4 package rows20250523_506fa28f-6f98-4632-bce8-72a9cb507c90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349553ARIPiprazole 20 MG Oral TabletPSN506fa28f-6f98-4632-bce8-72a9cb507c9015
349553aripiprazole 20 MG Oral TabletSCD506fa28f-6f98-4632-bce8-72a9cb507c9015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2806-07051828060030 POUCH in 1 BOX (70518-2806-0) > 1 TABLET in 1 POUCH (70518-2806-1) 30 pouch2020-07-060000-00-00NoNoCurrent
70518-2806-1705182806011 in 1 POUCHHistorical
70518-2806-27051828060230 TABLET in 1 BLISTER PACK (70518-2806-2) 30 tablet2021-05-120000-00-00NoNoCurrent
70518-2806-37051828060330 TABLET in 1 BLISTER PACK (70518-2806-3) 30 tablet2023-12-07NoNoHistorical